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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer
Position: Manager – Regulatory Affairs
Location: Vizag, Andhra Pradesh, India
The Position: The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.
What You Will Achieve
You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams. Due to your expertise, you will function as Product Owner for the assigned products of the Vizag tech transfer project to define the Global Regulatory strategy and ensure quality regulatory submission for successful transfer and commercial manufacturing.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Responsible for preparation and/or provide review support and guidance to product owners on technical and regulatory knowledge towards the preparation of Site transfer Global regulatory strategy document (GRSD), supplements/variations, and other regulatory documents
- Functions as product owner for site transfer submissions for assigned products, working with cross-functional site teams and corporate regulatory teams to ensure preparation of quality global regulatory strategy documents and supplements/variations.
- Provides guidance and support to Junior Product Owners in the preparation of quality global regulatory strategy documents and supplements.
- Responsible for effective coordination with the cross-functional teams at the site and corporate for the review and finalization of supplements to ensure effective data presentation and quality
- Responsible for effective review and providing timely feedback to the teams on technical documents related to transfer (Technology transfer protocols), batch documents related to submission (batch records, Exhibit batch, and stability protocol, etc.,)
- Provides regulatory support for Change assessment related to submissions from Vizag site
- Collaborates with and ensures adequate support to the regional team to ensure completion of assigned shared tasks or goals.
- Identifies, assesses regulatory risks associated with assigned projects and timely communication of the issues, its impact on global regulatory management & core team and drives resolution of issues
- Drives resolution of issues. Communicates issues, impact, and outcomes to global regulatory management, team lead, and the core team.
- Remains knowledgeable about current regulations and guidance interprets and implements in the assigned projects
- Responsible for ensuring compliance with the Company’s submission standards, policies, and procedures.
- Good oral and written English communication skills.
- Good conceptual, analytical, problem-solving, and organizational skills
- Well-organized and accustomed to maintaining excellent records
- Good knowledge of Microsoft Office tools
- Regulatory requirements for handling Technology Transfer activities and submission of supplements/variation to various global regulatory agencies especially USFDA and preferably EMA & other EU health Authorities, Health Canada, and TGA.
- ICH Quality Guidances
- Sterile injectable manufacturing and regulatory data requirements for submission.
- Good level of knowledge on general standards, processes, and policies of the Pharmaceutical manufacturing Industry.
Experience: Minimum 10 Years in leading independently or a team in the Regulatory Affairs function in a reputed pharmaceutical organization with major experience in handling new submissions/post-approval changes to health authorities especially USFDA, EMA, and other EU authorities. Experience in handling site transfer submissions is preferable.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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